System, Perfusion, Kidney

FDA product code KDN · 41 cleared devices

Class 2 Gastroenterology, Urology

Regulation: 21 CFR 876.5880
Review panel: GU
Implant: No
Life sustaining: No
Third party review: Yes
GMP exempt: No
Clearance span: 1983-05-27 – 2026-07-23

KDN 2026-07-23

Perfadex Plus

Applicant Xvivo Perfusion AB

K number K261644

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KDN 2026-06-01

VI°Port™ Liver Preservation System

Applicant Traferox Technologies, Inc.

K number K260456

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KDN 2026-01-30

BAROguard Donor Lung Preservation System

Applicant Paragonix Technologies, Inc.

K number K254305

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KDN 2025-06-17

EasiSlush® Sodium Chloride Solution for Sterile Slush Preparation (BTLE-1250)

Applicant Bridge TO Life

K number K243618

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KDN 2025-05-01

X°Port Lung Preservation System; X°Port Lung Preservation Solution

Applicant Traferox Technologies, Inc.

K number K243870

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KDN 2025-04-25

DCX Disposable Cassette (DCX)

Applicant Institut Geroges Lopez

K number K243998

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KDN 2025-03-31

Belzer UW® Cold Storage Solution (BTLBUW-001)

Applicant Bridge TO Life

K number K243384

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KDN 2025-03-26

Belzer MPS® (UW Machine Perfusion Solution) (BMPS-001)

Applicant Bridge TO Life

K number K243840

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KDN 2024-11-26

LungProtect

Applicant Traferox Technologies, Inc.

K number K240650

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KDN 2024-10-23

KIDNEYvault Portable Renal Perfusion System

Applicant Paragonix Technologies

K number K234060

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KDN 2023-09-21

Servator P Plus SALF Solution

Applicant S.A.L.F. Spa

K number K230193

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KDN 2023-08-15

BAROguard

Applicant Paragonix Technologies

K number K223874

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KDN 2022-01-20

KIDNEY ASSIST-transport

Applicant Xvivo Perfusion AB

K number K211333

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KDN 2021-10-15

RM4 Control Unit

Applicant Institut Georges Lopez

K number K211224

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KDN 2021-08-19

Servator P SALF Solution with THAM

Applicant S.A.L.F. Spa

K number K202652

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KDN 2021-07-01

Cannula for Organ Perfusion

Applicant Bridge TO Life, Ltd.

K number K203262

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KDN 2020-07-02

SherpaPak Pediatric Liver Transport System

Applicant Paragonix Technologies

K number K201048

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KDN 2020-01-16

SherpaPak Lung Preservation System , SherpaPak Liver Transport System

Applicant Pragonix Technologies

K number K192869

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KDN 2019-12-20

Paragonix SherpaPak Pancreas Transport System

Applicant Paragonix Technologies

K number K191440

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KDN 2019-09-24

EasiSlush

Applicant Bridge TO Life, Ltd.

K number K191006

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KDN 2018-06-29

Servator B SALF Solution

Applicant S.A.L.F. Spa

K number K180481

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KDN 2018-06-22

Perfadex Plus

Applicant Xvivo Perfusion AB

K number K170826

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KDN 2016-02-19

Low Potassium Dextran Solution with Tris Diluent

Applicant United Therapeutics Corporation

K number K153384

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KDN 2012-02-16

WAVES

Applicant Waters Medical Systems, LLC

K number K111521

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KDN 2010-10-01

PERFADEX AND PERFADEX WITH THAM

Applicant Xvivo Perfusion AB

K number K091989

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KDN 2009-06-17

COSTORSOL

Applicant Preservation Solutions, Inc.

K number K091245

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KDN 2009-01-21

COSTORSOL

Applicant Preservation Solutions, Inc.

K number K083453

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KDN 2008-08-08

MAPERSOL

Applicant Preservation Solutions, Inc.

K number K080432

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KDN 2008-07-03

COSTORSOL

Applicant Preservation Solutions, Inc.

K number K073693

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KDN 2004-10-22

RM3 RENAL PRESERVATION SYSTEM

Applicant Waters Instruments, Inc.

K number K042224

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KDN 2003-07-31

LIFEPORT, KIDNEY PERFUSION TRANSPORTER (KTR)

Applicant Organ Recovery Systems, Inc.

K number K021362

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KDN 2002-10-21

MODIFICATION TO KPS-1, KIDNEY PERFUSION SOLUTIION

Applicant Organ Recovery Systems, Inc.

K number K022391

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KDN 2002-01-25

KPS-I, THE KIDNEY PERFUSION SOLUTION

Applicant Organ Recovery Systems, Inc.

K number K013575

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KDN 1999-12-10

CUSTODIOL

Applicant Dr. Franz Kohler Chemie GmbH

K number K992209

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KDN 1999-11-04

HPA PORTABLE KIDNEY PRESERVATION SYSTEM, MODEL J-1000-1

Applicant Justec Medical Products, Inc.

K number K990229

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KDN 1997-11-26

BELZER-MPS

Applicant Trans-Med Corp.

K number K972066

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KDN 1997-07-29

RM3 RENAL PRESERVATION SYSTEM--CONTROL UNIT

Applicant Waters Instruments, Inc.

K number K971571

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KDN 1991-11-01

K-SOL(TM)

Applicant Alcon Laboratories

K number K911587

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KDN 1987-03-05

KIDNEY PERFUSION MACHINE

Applicant Advanced Equipment Development, Inc.

K number K864140

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KDN 1984-06-07

KIDNEY TRANSPLANT CATHETER

Applicant Warne Surgical Products, Ltd.

K number K840687

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KDN 1983-05-27

REDOX CONTROLLER

Applicant St. Louis Univ. Medical Center

K number K830994

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